BEUDAMED
    FDA Adverse Event Other Summary report: N

    C8000 ALBUMIN BCP

    MDR report key: 863569 · Received June 8, 2007

    Report

    Report Number
    2018433-2007-00030
    Event Type
    Other
    Date Received
    June 8, 2007
    Date of Event
    May 16, 2007
    Report Date
    May 16, 2007
    Manufacturer
    ABBOTT MANUFACTURING, INC
    Product Code
    CJW
    PMA / PMN Number
    K981814
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER NOTED THAT NO FURTHER ASSISTANCE WAS REQUIRED, BUT THEN OFFERED A FURTHER EXPLANATION RELATING TO THE EVENT. THE CUSTOMER HAS ARTHRITIS AND FINDS THE BOXES DIFFICULT TO OPEN WITHOUT THE USE OF A CUTTING INSTRUMENT. THE CUSTOMER STATED THAT NO BLOOD SPLASHED ONTO HER LAB COAT OR FACE SHIELD. NO MENTION OF WHETHER THE CUSTOMER WAS USING GLOVES AT THE TIME OF THE EVENT. THE CUSTOMER IS FINE AND RETURNED TO WORK AFTER RECEIVING THE STITCHES. THE INVESTIGATION DEMONSTRATED THAT THE ABBOTT CLINICAL CHEMISTRY ALBUMIN BCP ASSAY WAS NOT THE CAUSE OF THE EVENT AND THAT THE PRODUCT CONTINUES TO PERFORM WITHIN ITS INTENDED USE, LABEL CLAIMS AND SPECIFICATIONS. NO DEFICIENCY RELATED TO THE PERFORMANCE OF THE DEVICE WAS IDENTIFIED. THIS IS A FINAL REPORT.

    Description of Event or Problem · 1

    A LABORATORY TECHNICIAN WAS ATTEMPTING TO OPEN A CARTON OF THE CLINICAL CHEMISTRY ALBUMIN BCP REAGENT FOR USE ON THE ARCHITECT C8000 ANALYZER. THE TECHNICIAN WAS USING A BOX CUTTER KNIFE TO OPEN THE CARTON. THE CUTTER BECAME STUCK DURING THIS PROCEDURE AND WHEN THE TECHNICIAN MOVED THE KNIFE DOWNWARD, SHE CUT HER THUMB. THE TECHNICIAN WENT TO THE EMERGENCY DEPARTMENT AND RECEIVED FIVE STITCHES. NO FURTHER TREATMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 C8000 ALBUMIN BCP QUANTITATION OF ALBUMIN IN HUMAN SERUM OR PLASMA CJW ABBOTT MANUFACTURING, INC NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other ARCHITECT C8000 PRC MOD LIST#: 1G06-01